Implantable Custom Made (Autogenous) Biologics

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Occasionally diseases occur for which there are no commercially available vaccines or bacterins. Similarly, although "off-the-shelf" products may be available and labeled to prevent a specific disease, they may not be effective due to strain or antigenic variation between the vaccine and the pathogen in the field.

By definition, autogenous biologics (bacterins and vaccines) are custom-made from the bacteria or virus causing disease in a livestock operation. The resulting product is specific to the pathogenic strain(s) in that herd or feedlot. The USDA regulates the use of biologics in food animals, and allows the use of autogenous biologics in situations that meet certain criteria.

In some cases commercially available "one-size-fits-all" generic combination vaccines may not contain the desired antigen, or may contain others not desired in the individual situation. Autogenous vaccines offer the veterinarian and producer the ability to formulate a combination product customized for the producer, but not available commercially.

Newport Laboratories’ autogenous vaccines and bacterins are produced in a USDA-licensed facility according to strict guidelines established by that agency. Autogenous products are intended for use by, or on the order of a licensed veterinarian who has a veterinary-client-patient relationship with the producer. The implantable or "SoliDose®®" autogenous version requires reformulation of the Newport liquid product at SolidTech Animal Health, also a USDA-licensed facility operating according to USDA guidelines.

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Getting Started

The first step in developing an autogenous vaccine or bacterin is identifying and isolating the causative agent related to the disease. Typically this involves the attending veterinarian submitting the appropriate tissue samples to a diagnostic laboratory. These samples may be sent to a state diagnostic lab or directly to Newport Labs.

If/when the lab isolates a pathogen, that organism serves as the "seed" for an eventual autogenous bacterin or vaccine. If the initial diagnostic work is performed at a state lab, the submitting veterinarian can request that the isolate be forwarded to Newport Labs. Similarly isolates held by another autogenous biologics manufacturer can be forwarded to Newport at the veterinarian’s request. Isolates forwarded to Newport Labs will be checked for purity and to confirm the proper identification.

In some situations additional testing, usually using PCR technology, will be necessary to identify virulence factors (e.g. toxins, antigens, etc.) and/or detect strain variation between various isolates. These molecular diagnostic tests aid in selection of the appropriate isolates for use in a vaccine or bacterin.

Once the isolates are selected, the submitting veterinarian is contacted to confirm the intention to produce an autogenous vaccine. At that time, the decision is made regarding number of doses and dose size. The adjuvant type is also selected based on the particular antigen in the product and other factors. The decision of using conventional fluid or the new SoliDose® implantable form would also be made at this time.

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Production

The selected organisms (seed isolates) are transferred from the Newport Diagnostic Facility to the Production facility. Viruses are inoculated onto the appropriate cell cultures and bacteria are cultured in nutritive media for growth. The process of growing the organisms continues in multiple steps until the quantity is sufficient for the number of doses of product requested.

The growth of the organisms is closely monitored using criteria specific to that bacteria or virus. Once the desired quantity and concentration is achieved, the resulting "final fluids" containing the organisms are then harvested and an inactivating agent added. The end result is a highly concentrated fluid containing the inactivated bacteria or virus. If the final product is to be a combination of multiple antigens, the respective final fluids will be combined in strict accordance with a previously calculated formulation.

Following quality control testing, the inactivated, adjuvanted product is then transferred to SolidTech where the liquid product is processed into the SoliDose® implant pellets. Once reformulated, additional quality control testing occurs and the product is "released" by the USDA. The entire serial is then stored in Newport’s huge product cooler to await distribution.

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Quality Control (QC)

All Newport and SolidTech autogenous products are sampled and tested for safety and purity, using a battery of lab animal and in vitro procedures. Once the QC tests are completed satisfactorily, the required paperwork is submitted to the USDA for approval. This complete process takes just over two weeks. As soon as the USDA approves the release, labels are applied to the bottles (in a color selected by the veterinarian) and shipped to the clinic, or in some cases directly to the producer (as directed by the veterinarian).

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Product Use and Technical Support

Newport / SolidTech autogenous bacterins and vaccines are intended for use by the attending veterinarian, or by his/her client at the direction of the veterinarian. The product label contains all the necessary information, including the antigens contained in the product and the directions for proper use. All bovine products are labeled for subcutaneous injection or implantation, consistent with BQA recommendations. Implanted products may be administered in the base of the ear or in the neck.

If the producer or veterinarian has questions regarding the dosage regimen, or any product or disease related issues, Newport has a Technical Services department to address those questions. This group is composed of experienced, knowledgeable animal health professionals (veterinarians and researchers).

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